Introduction to NIAIC
The Northern Ireland Adverse Incident Centre (NIAIC) operates as a function of the DoH with the objective of taking all reasonable action within its remit to safeguard the health of HSC service-users and staff through the provision of a regional centre for the voluntary reporting and investigation of adverse incidents involving medical devices, non-medical equipment, plant and building elements and for providing relevant safety guidance in relation to these items.
Types of Safety Information
NIAIC has direct links with the Medicines and Healthcare products Regulatory Agency (MHRA) who co-ordinate information across the adverse incident centres in England, Scotland, Wales and Northern Ireland for issues concerning medical device safety. NIAIC also has links with Estates and Facilities Division - Department of Health UK and other bodies for safety issues concerning non-medical equipment, plant and building items.
NIAIC issues the following Safety Information:
The Medicines and Healthcare products Regulatory Agency (MHRA) is now an accredited issuer of National Patient Safety Alerts, a format devised by NHS England. National Patient Safety Alerts are alerts that require local executive management level action to reduce the risk of death or serious harm. These alerts follow the criteria and template agreed by the National Patient Safety Alerting Committee (NaPSAC) and are not be limited to medical device issues. Therefore, MHRA medical device alerts will be interleaved with other Patient Safety Alerts and the reference numbers for medical device alerts may not hold a consecutive reference number. The NIAIC will continue to require assurance on this type of alert via the NICAS
A NatPSA may come about as a result investigation by any of the UK administrations where the manufacturer cannot demonstrate they have taken appropriate action. Alternatively they can result through other information received by the MHRA from Competent Authorities around the world.
Estates and Facilities Alerts
Estates and Facilities Alerts (EFA's) are the prime means of communicating safety and potential estate and facility risks to the estates personnel in the healthcare environment. EFA's may also be used to provide updated information on previously published alerts. EFA‘s are prepared in consultation with other regions and are distributed nationally.
NIAIC Alerts (NIA's)
Following the investigation of an adverse incident report, NIAIC may determine that it is necessary to publish targeted safety guidance for Northern Ireland and issue a NIA.
NIAIC also publishes other safety and related guidance in relation to medical devices. This can be in the form of Medical Device Safety Information (MDSI) or other relative formats.
NIAIC places high importance on the open reporting of adverse incidents. Part of our work is encouraging a shift to a safety culture in the HSC, where open reporting and balanced analysis are encouraged in principle and by example to achieve continual improvement and learning in patient and staff safety. This is in contrast to a blame culture, which can encourage people to cover up errors for fear of retribution and can act against the identification of the true causes of failure due to focusing on individual actions and not taking account of the role of the underlying systems.
For this reason NIAIC also encourages the reporting of any minor faults and discrepancies, since they may take on a greater significance when aggregated with other similar events in demonstrating trends or may be indicators of inadequate quality assurance on the part of the manufacturer or supplier.